Author Archives: Joana Carvalho

FDA Partially Rescinds Indications for BeneFIX and Ixinity

Owing to conflicting market exclusivity rights, the U.S. Food and Drug Administration (FDA) has partially rescinded its decision to approve BeneFIX and Ixinity for additional indications both therapies received last year for the treatment of hemophilia B, according to the National Hemophilia Foundation. Pfizer’s BeneFIX and…

Efanesoctocog Alfa on Fast Track for Hemophilia A

The U.S. Food and Drug Administration (FDA) has granted fast track designation to efanesoctocog alfa, an investigational factor VIII (FVIII) replacement therapy for treating hemophilia A, Sanofi, one of the therapy’s developers, announced in a press release. This designation is given to accelerate the development and review of…

Top 10 Hemophilia Stories of 2020

Hemophilia News Today brought you daily coverage in 2020 of important discoveries, treatment advancements, clinical trial findings, and other important events related to hemophilia. As we look forward to bringing you more news this year, we present here the 10 most-read stories of 2020, along with a summary of…

Roche Proposes Transfer Needle With Filter When Using Hemlibra

Reports of translucent particles of being detected in Hemlibra (emicizumab) in 2019 do not pose a safety risk or affect the therapy’s effectiveness and, according to Roche, health authorities have agreed that the treatment’s benefit/risk profile remains unchanged. Yet, the company is proposing the use of a…